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Guanylate Cyclase-C Agonist
Linaclotide for Chronic Constipation in Type 2 Diabetes
Phase 4
Waitlist Available
Led By Irene Sarosiek, MD
Research Sponsored by Texas Tech University Health Sciences Center, El Paso
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 weeks
Awards & highlights
Study Summary
This trial has two phases. In the first phase, patients are randomly assigned to receive either the active drug or a placebo for 14 days. In the second phase, the order is reversed. There is a 2-week break in between phases during which patients do not receive any medication. The trial is closely monitored for safety.
Who is the study for?
This trial is for Type II diabetics who've had chronic constipation for at least 6 months, with hard or lumpy stools. They should have less than three spontaneous bowel movements per week and not be using laxatives frequently. People with severe diseases, high hemoglobin A1c levels (>8.2), drug/alcohol abuse, certain gastrointestinal surgeries, or severe hemorrhoids can't join.Check my eligibility
What is being tested?
The study tests Linaclotide against a placebo in people with diabetes and chronic constipation over two phases of 14 days each, separated by a two-week break. Participants are randomly assigned to start with either the active drug or placebo and then switch after the break.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be closely monitored for any adverse reactions during their five visits throughout the trial period.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improvement in frequency of bowel movements
Trial Design
2Treatment groups
Active Control
Group I: 1)28days of linaclotide or placeboActive Control1 Intervention
patient will be randomized and allocated to one of the treatment arms using computerized generated simple random number in a double-blinded fashion for 28 days of therapy with the study drug, linaclotide or placebo. Patients, and trial personnel involve (other than biostatistician) in this study will not be aware of the group assignments. Patients, treatment providers and staffs will be kept blinded in this study.
Group II: 2)28days of linaclotide or placeboActive Control1 Intervention
patient will be randomized and allocated to one of the treatment arms using computerized generated simple random number in a double-blinded fashion for 28 days of therapy with the study drug, linaclotide or placebo. Patients, and trial personnel involve (other than biostatistician) in this study will not be aware of the group assignments. Patients, treatment providers and staffs will be kept blinded in this study.
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Who is running the clinical trial?
Texas Tech University Health Sciences Center, El PasoLead Sponsor
49 Previous Clinical Trials
5,097 Total Patients Enrolled
Irene Sarosiek, MDPrincipal InvestigatorTexas Tech University Health Sciences Center- El Paso, Texas
3 Previous Clinical Trials
127 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I regularly take NSAIDs more than three times a week.I do not have any severe illnesses that my doctor thinks should keep me out of the study.I haven't used laxatives (except fiber) 3 days before joining, and won't use them often during the trial.I struggle significantly with bowel movements due to pelvic floor issues.I have type II diabetes.I have been constipated for at least 6 months.I've had loose or watery stools for more than 25% of the time without taking laxatives.I have not taken drugs like domperidone, opiates, or anti-spasmodics in the last 3 days.I do not use illegal drugs.I drink more than 2 alcoholic beverages daily.I have or had severe diverticulitis and hemorrhoids.I have had constipation for over 6 months with hard stools and often feel incomplete after going.Your hemoglobin A1c level is higher than 8.2.I have had surgery on my stomach or part of my colon removed.You have frequent hard or lumpy stools, based on a specific scale used to describe stool appearance.I have severe gastroparesis, need tube feeding, often hospitalized, or have a gastric neurostimulator.I have fewer than three bowel movements per week.I have diabetic nerve pain or stomach issues like GERD.I have been diagnosed with functional constipation.You have been diagnosed with Diabetic Autonomic Neuropathy using the ANX 3.0 real-time ANS monitoring system.
Research Study Groups:
This trial has the following groups:- Group 1: 1)28days of linaclotide or placebo
- Group 2: 2)28days of linaclotide or placebo
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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